Comparison of Three Different Prophylactic Treatments of Postoperative Nausea and Vomiting (PONV) in Children

Phase 4

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Drug: Dexamethasone; Drug: Dexamethasone and droperidol; Drug: Dexamethasone and Ondansetron

• Registration Number: NCT01434017
• Lead Sponsor: Centre Hospitalier Universitaire Vaudois

Brief Summary

Incidence of postoperative nausea and vomiting (PONV) in children after tonsillectomy with or without adenoidectomy may be as high as 75%.

Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic antiemetic treatments:

* dexamethasone alone (250 mcg/kg)

* dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg)

* dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).

Detailed Description

Tonsillectomy with or without adenoidectomy may be associated with severe postoperative nausea and vomiting (PONV). Causes are principally trigeminal nerve stimulation and presence of blood in the stomach. Consequences are disagreement, unsatisfactory, delayed discharge, and overnight admission in day-cases. More barely, patients may also have suture and esophagus rupture, aspiration of gastric contents, dehydration and electrolyte disturbances.

Several medications may prevent and treat PONV, such as steroids, antidopaminergic drugs and serotonin (5-HT3) antagonists. The objective of this study is to compare three prophylactic antiemetic treatments:

* dexamethasone alone (250 mcg/kg)

* dexamethasone (250 mcg/kg) + droperidol (10 mcg/kg)

* dexamethasone (250 mcg/kg) + ondansetron (150 mcg/kg).

The hypothesis is that the combination of dexamethasone and droperidol is as effective as the combination of dexamethasone and ondansetron, both of them being more effective than dexamethasone alone. Moreover, droperidol is cheaper than ondansetron and may be recommended as a first-line treatment.

Study Timeline

• Study Start: 2008-11
• Study First Submitted: 2011-09-13
• Study First Submitted QC: 2011-09-13
• Study First Posted: 2011-09-14
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-26
• Last Update Posted: 2014-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• children aged 2-10 y.
• children ASA 1-2
• weight > 15 kg
• tonsillectomy with or without adenoidectomy

Exclusion Criteria

• intravenous induction
• contraindication to steroids
• contraindication to antidopaminergic drugs
• contraindication to serotoninergic antagonists
• administration of steroids, antidopaminergic drugs, or serotoninergic antagonists in the 24 hours before the surgery
• refusal of parents
• no-french speaking parents

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexamethasone	Dexamethasone	Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
Dexamethasone and Droperidol	Dexamethasone and droperidol	Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
Dexamethasone and Ondansetron	Dexamethasone and Ondansetron	Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.

Primary Outcome Measures

Name	Time	Method
Incidence of PONV after tonsillectomy with or without adenoidectomy	48 hours

Secondary Outcome Measures

Name	Time	Method
Incidence of side effects (extrapyramidal syndrome, hemorrhage, somnolence, headaches)	48 hours

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois and University of Lausanne; 🇨🇭 Lausanne, Vaud, Switzerland